We are seeking effective management and control of all organizational documentation. Responsible for organizing and coordinating activities of the QS Documentation team in a time-sensitive manufacturing environment. Including collaborating with cross-functional teams to advance the efficiency of documentation processes throughout the GMP environment. Responsible for monitoring key metrics while the document change process is aligned with company policies and regulatory requirements. This role is responsible for maintaining documents and ensuring consistent organization and retrieval through established naming conventions and filing systems. Managing the lifecycle of documents, including receiving, reviewing, processing, issuing, and archiving.
Key Responsibilities/Essential Functions
Categorize/Group Responsibilities:
Implement ways to simplify business processes and documentation strategies, to increase efficiency, ensure compliance, and reduce documentation maintenance requirements.
Coordinates, proofreads, formats, and troubleshoots issues for controlled documents
Track metrics and generate reports summarizing the findings and providing clear documentation for future reference.
Manages multiple tasks in a fast-paced and dynamic environment while maintaining focus on quality and compliance with local SOPs, policies and directives, and regulatory requirements.
Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment.
Actively demonstrates values of accountability, quality, efficiency, customer service, collaboration, and safety.
Basic Qualifications
Education/Experience qualifications: AS in English or Science.
Document Control and/or technical writing experience preferred
A combination of education, training, and experience may be considered instead of the above-stated qualifications.
Persona example: This position is site-based and requires a presence on-site three days per week.
Other Requirements
Experience in the pharmaceutical industry, preferably within the Quality
Proficient in Microsoft Office
Proficient in advanced functions of Microsoft Word
Excellent verbal and written communication
Ability to work independently
Able to identify and present solutions that will resolve issues and meet the required due dates for documents